BPN-Biologics Resources

Researchers participating in the Blueprint Neurotherapeutics Network for Biologics receive grant funding (a UG3/UH3 award or U44 award if a small business) and no-cost access to biotherapeutic development consultants and contract research organizations (CROs).

Research Grants (UG3/UH3 or U44)

All projects that enter BPN-Biologics begin with a UG3 phase (or U44 Phase I) of up to two years, which should be used to complete all lead optimization activities (for Discovery-stage projects) or any additional preparatory activities needed to initiate IND-enabling studies (for Development-stage projects). This phase will also be used to engage the LDT in establishing a detailed research plan and go/no-go milestones for all subsequent work.

Projects can enter BPN-Biologics during the Discovery or Development stage and may seek support through phase I/first-in-human testing. Discovery involves biologic agent characterization and optimization in order to identify a suitable development candidate. During the Development stage, a candidate undergoes preclinical toxicology testing required for an IND and manufacturing, ultimately advancing to phase I/first-in-human testing. BPN-Biologics-supported Development activities include chemical manufacturing and controls (CMC), formulation development, toxicology studies, regulatory support, and phase I/first-in-human testing.

Image
Breakdown of 5-year funding cycle

Consultants

Each Lead Development Team receives support from BPN-Biologics consultants. Consultants are assigned to a project with considerations for the project team's individual needs and consultants' expertise.

Current Consultants

U44 mechanism comparison to other potential mechanisms for small business applicants

 STTR and SBIR Omnibus program

BPN-Biologics

R43/R44 mechanism

U44 mechanism

Broad modalities of product development (including, but not limited to, small molecules, technologies, devices, biologics, etc.)

Limited to biologics development only (e.g., antibodies, peptides, proteins, oligonucleotide- and viral-based gene therapies, cell therapies, and other novel emerging therapies (e.g., microbial and microbiome therapies).

Indications are extremely broad

Indications are specified by participating institutes.

More competitive due to the number of applications

Not as competitive in terms of applications’ number

All stages of product development, no hard criteria for phase 1 entry.

Limited to the late stage of pre-clinical product development & optional clinical trials.

Budget is limited:
SBA hard cap -
Phase 1: $275,766 for (6 months-2 years)
Phase 2: $1,883,436 (2-3 years)
Waiver limits –
Phase 1: $700,00 for (cap of $500,000/year)
Phase 2: $3,000,000 (cap of $1,500,00)

Budget does not have a hard cap but should be within recommended frame:
Phase 1: up to $500K/year (up to 2 years)
Phase 2: up to 1.5M/year (no more than 3 years)

Granted funding

Granted funding + support (NIH experts, consultants and CROs contracted by NIH)

NIH scientific program staff do not collaborate on project activities after the award

After the award, NIH scientific program staff will assist, guide, coordinate, or participate in project activities

Milestones are only for Fast-Track mechanism (combined Phase I and Phase 2 award)

Milestones are set by Lead Development Team and must be met in order to move the project further. If milestones are not feasible to achieve, the project will be discontinued.

Can be used as a preparation stage prior the application to BPN-Biologics.

 

 

UG3/UH3 BPN-Biologics

U44 BPN-Biologics (SBIR Fast-track)

Eligibility: Higher Education Institutions, Non-profits, Local Governments, Federal Government Agencies, Small Businesses & Other For-Profit Organizations, Others.  

Eligibility: Only U.S. small business concerns (SBCs)

 

Additional support is available through SEED program for small business aspects

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

No specific requirements for PD/PI primary employment

The Project Director/Principal Investigator (PD/PI) must have his/her primary employment with the small business concern at the time of award and for the duration of the project period

UG3/UH3 projects are 100% funded by BPN-Biologics program and might have limitations due to funds availability

The funding of the grant comes from SBIR program, a Federally mandated set-aside, which can only fund small businesses.

Data sharing is essential

Data sharing is not mandatory; the data are protected for 20 years. See SBIR data right FAQ .

A commercialization plan is developed and updated over the course of the project.

A commercialization plan is expected in the application: a realistic plan (extending beyond the U44 Phase II) which outlines how and when full commercialization can be accomplished.

 

 

Contract Research/Manufacturing Organizations

BPN researchers receive no-cost access to the network's Contract Research Organizations (CROs). LDTs plan and coordinate studies conducted by BPN CROs.

The list of CROs/CMOs to be decided.

Informational Resources

Examples of Activities for BPN-Biologics Projects(pdf, 176 KB)

Example of Product Development Swim Lane BPN-Biologics(pdf, 194 KB)

NIH Stem Cell Information

FDA Guidance Documents

FDA CBER Standard Operating Procedures and Policies (SOPPs)

Example Target Product Profiles:

                  Target Product Profile (TPP)(pdf, 189 KB) 

Example Agent Profiles: 

                   Example Antibody Profile(pdf, 100 KB) 
                   Example Antisense Oligonucleotide Profile(pdf, 105 KB) 
                   Example Viral Gene Therapy Profile(pdf, 118 KB) 
                   Example Peptide or Protein Profile(pdf, 100 KB) 

 

BPN-Biologics Staff

Program Director
Dr. Chris Boshoff

Health Program Specialists
Ms. Shruthi Thomas

 

Project Managers

Ms. Elena Barnaeva
Ms. Sonia Gales

Operations Coordinator
Ms. Natasha Davis

CONTACT US